Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-29 @ 5:31 AM
Study NCT ID:
NCT01474304
Status:
UNKNOWN
Last Update Posted:
2016-09-29
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Acetaminophen for Craniotomy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total narcotic dose administered over the first 12 hours of postoperative recovery.', 'timeFrame': '12 hours', 'description': 'Intensive care nurses will ask subject about pain and nausea every 15 minutes for the first two hours immediately after surgery and then every hour afterward for up to 12 hours. Nurses will record subject response and opioid doses given.'}], 'secondaryOutcomes': [{'measure': 'Incidence of nausea during postoperative recovery', 'timeFrame': '12 hours'}, {'measure': 'Incidence of vomiting during postoperative recovery', 'timeFrame': '12 hours'}, {'measure': 'Severity of nausea during postoperative recovery', 'timeFrame': '12 hours'}, {'measure': 'Severity of vomiting during postoperative recovery', 'timeFrame': '12 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['craniotomy', 'tumor resection', 'aneurysm', 'revascularization', 'opioid', 'nausea', 'vomiting', 'acetaminophen'], 'conditions': ['Craniotomy']}, 'descriptionModule': {'briefSummary': 'Adding intraoperative IV acetaminophen, in addition to standard analgesics, will decrease opioid requirements over the first 12 hours of postoperative recovery following craniotomy. Opioids exacerbate symptoms of nausea and vomiting. Reducing postoperative opioid use hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 years of age\n* Weigh at least 50 kg (110.23 lbs)\n* Undergoing open, elective intracranial procedure for\n\n * tumor resection\n * aneurysm clipping\n * revascularization\n* Have an ASA (American Society of Anesthesiologists) physical status of 1, 2, 3, or 4\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Significant medical disease, laboratory abnormality, or condition that, in the opinion of the investigator, would compromise patient welfare or would otherwise contraindicate study participation\n* Unable to communicate symptoms\n* Current daily opioid use (\\>40 mg morphine equivalent)\n* Tramadol use\n* Treated with MAO (monoamine oxidase inhibitors) inhibitors within 10 days of surgery\n* Treated with any amount of acetaminophen within 8 hours of anesthesia for surgery\n* Allergic or hypersensitive to acetaminophen or any contraindications per manufacturer's guidelines\n* Pregnancy\n* Impaired liver function\n* Participation in interventional clinical study within the last 30 days\n* Known or suspected history of alcohol or drug abuse\n* Surgery for resection of acoustic neuroma\n* Transphenoidal tumor resection"}, 'identificationModule': {'nctId': 'NCT01474304', 'acronym': 'IVAC', 'briefTitle': 'Intravenous Acetaminophen for Craniotomy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Swedish Medical Center'}, 'officialTitle': 'Intravenous Acetaminophen for Craniotomy Patients: A Single-blinded, Randomized Controlled Trial to Evaluate the Effect of Intravenous Acetaminophen Administered at Induction and Emergence From Craniotomy', 'orgStudyIdInfo': {'id': 'IVAC'}, 'secondaryIdInfos': [{'id': '20111619', 'type': 'OTHER', 'domain': 'Western Institutional Review Board (WIRB)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acetaminophen', 'description': 'Craniotomy patients will receive a 1000 mg dose of intravenous (IV) acetaminophen before incision and a second 1000 mg dose of IV acetaminophen 6 hours later.', 'interventionNames': ['Drug: Acetaminophen']}, {'type': 'NO_INTERVENTION', 'label': 'No acetaminophen', 'description': 'Patients will receive standard of care with no intraoperative doses of acetaminophen.'}], 'interventions': [{'name': 'Acetaminophen', 'type': 'DRUG', 'description': '1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery', 'armGroupLabels': ['Acetaminophen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Swedish Medical Center Cherry Hill Campus', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Becky Wood', 'role': 'CONTACT', 'email': 'becky.wood@swedish.org', 'phone': '206-320-7115'}, {'name': 'Nathan Hansen', 'role': 'CONTACT', 'email': 'nathan.hansen@swedish.org', 'phone': '206-320-3542'}], 'overallOfficials': [{'name': 'Arthur Lam, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swedish Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallinckrodt', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}